Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g in...
FDA Recall #D-382-2014 — Class III — December 4, 2013
Product Description
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
Reason for Recall
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Recalling Firm
Teva Pharmaceuticals USA — Horsham, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
379,463 inhalers
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated